SGLT2 Inhibition in Diabetic Patients With Heart Failure With Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- SGLT2 inhibition effects on cardiorespiratory fitness (CRF).
研究概览
简要总结
To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure.
详细描述
The investigators hypothesize that Sodium-GLucose coTransporters (SGLT)-2 inhibition will improve cardio-respiratory fitness (CRF) in patients with systolic heart failure.
Participants treated with SGLT2 inhibitor Empagliflozin as standard of care will undergo assessments described below.
The investigators will measure CRF with a validated cardiopulmonary exercise test at baseline and after 4 weeks of treatment received as standard of care, to determine whether SGLT2 inhibition improves cardio-respiratory fitness assessed by changes in peak oxygen consumption (VO2)(mL/kg/min) and minute ventilation (VE)/carbon dioxide production (VCO2) slope, powerful independent clinical predictors of mortality in HF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical diagnosis of stable HF (NYHA class II-III) on maximally tolerated HF medical regimen including angiotensin-inhibitors, beta-adrenergic blockers, and loop diuretics
- •Reduced left ventricular systolic function (LVEF<50%) documented in the prior 12 months
- •Poorly controlled T2DM (HbA1c levels between 6.5% and 10.0%)
- •18 years old and older.
排除标准
- •Type I diabetes;
- •Type II diabetes with episodes of severe hypoglycemia <50 mg/dl by history, frequent changes in anti-diabetic regimen class in the past 3 months or with a prior episode of diabetic ketoacidosis (any time);
- •Open label treatment with SGLT2 inhibitors (within the past month);
- •Treatment with thiazolidinedione (within the past month), which may induce volume and sodium retention;
- •Chronic Kidney Disease (GFR<45 ml/kg*min);
- •Uncontrolled thyroid dysfunction (TSH<0.4>4.5 mcIU/ml);
- •Pregnancy or of child-bearing potential;
- •Active or recent (within 2 weeks) genital/urinal infection;
- •Concomitant conditions or treatment which would affect completion or interpretation of the study including physical inability to walk or run on a treadmill such as decompensated HF (edema, NYHA class IV), significant ischemic heart disease, angina, arterial hypotension (BP systolic <90 mmHg), orthostatic arterial hypotension, arterial hypertension (resting BP systolic >160 mmHg), atrial fibrillation with rapid ventricular response, severe valvular disease, severe chronic obstructive or restrictive pulmonary disease, moderate- severe anemia (Hgb<10 g/dl);
- •Abnormal BP or heart rate response, angina or ECG changes (ischemia or arrhy- thmias) occurring during baseline cardio-pulmonary exercise testing;
- •Chronic use of oral corticosteroids;
- •Inability to give informed consent.
结局指标
主要结局
SGLT2 inhibition effects on cardiorespiratory fitness (CRF).
时间窗: 4 weeks
To measure the effects of Empagliflozin on cardiorespiratory fitness in patients with type 2 diabetes and heart failure with reduced ejection fraction or systolic heart failure. The effects on CRF are determined by measuring changes in peak VO2 (mL/kg/min) and the VE/VCO2 slope.
次要结局
未报告次要终点